Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy (EPICAT)

May 31, 2023 updated by: University Hospital, Toulouse

Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy Catamenial Epilepsy: Status Report and Point of View of a Cohort of Patients Who for Drug-resistant Epilepsy at the TOULOUSE University Hospital

This is a study of patients with catamenial epilepsy. Catamenial epilepsies are defined as epileptic seizures during the menstrual cycle. Today, there are no recommendations and no care pathway for these patients. The aim of this study is to assess the number of patients reporting a link between the occurrence of their epileptic seizures and their menstrual cycle.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital TOULOUSE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with catamenial epilepsy

Description

Inclusion Criteria:

  • Adults patients (>18 years)
  • No menopausal
  • Patients who have consulted in a Neurology department for refractory epilepsy
  • Non opposition patient
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Patients who understand French enough

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients with catamenial epilepsy
A questionnaire regarding the menstrual cycle and the catamenial epilepsy will be administrated to the participants.
Other: Data collection
A collection about patient's data demographic, neurologic and gynecologic follow-up and satisfaction will be review by questionnaire. And a calendar of epileptic seizures will be completed by patients on 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of reporting patients
Time Frame: 4 months
Number and proportion of patients reporting having a link between the onset of their epileptic seizures and their menstrual cycle based on the questionnaire they completed.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Listening satisfaction
Time Frame: 4 months
Questionnaire about listening satisfaction by the professional
4 months
Satisfaction of taking charge
Time Frame: 4 months
Questionnaire about satisfaction of management by the professional
4 months
Rate of women with drug-resistant epilepsy
Time Frame: 4 months
Collection calendar
4 months
Reconciliation of catamenial epilepsy
Time Frame: 4 months
Comparison of epilepsy collection calendar and questionnaire. The questionnaire includes demographic data, neurological demographic data, their neurological and gynaecological follow-up, and also their satisfaction with their care and the information received on their pathology.
4 months
Association between catamenial epilepsy and menstrual cycle
Time Frame: 4 months
Research of an association between catamenial epilepsy and menstrual cycle
4 months
Existing associations
Time Frame: 4 months
Evaluate link between different factors obtained during the collection (contraceptions, epileptics, menstrual cycle disorders, etc.) and the presence of catamenial epilepsy
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Anna GOSSET, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Estimated)

May 3, 2024

Study Completion (Estimated)

November 3, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0055
  • 2023-A00280-45 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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